Mini keyhole operation versus standard keyhole operation for removal of the gallbladder

About 10% to 15% of the adult western population have gallstones. Between 1% and 4% become symptomatic each year. Removal of the gallbladder (cholecystectomy) is the mainstay treatment for symptomatic gallstones. More than half a million cholecystectomies are performed per year in the United States alone. Laparoscopic cholecystectomy (removal of gallbladder through a key-hole, also known as port) is now the preferred method of cholecystectomy. In standard port laparoscopic cholecystectomy, four ports (two of 10 mm diameter and two of 5 mm diameter) are usually used. Recently, use of smaller ports has been reported (miniport laparoscopic cholecystectomy). However, the safety of miniport laparoscopic cholecystectomy and whether it offers any advantages over standard port laparoscopic cholecystectomy is not known. We sought to answer this question by reviewing the medical literature and obtaining information from randomised clinical trials. When conducted well, such studies provide the most accurate information. Two authors searched the literature and obtained information from the studies thereby minimising errors.

We identified 12 randomised clinical trials involving 734 patients that compared miniport laparoscopic cholecystectomy (380) with standard port laparoscopic cholecystectomy (351). The choice of the treatment that the patients received was determined by a method similar to toss of coin so that both treatments were conducted in patients who were as similar as possible. Most of the trials were of high risk of bias, i.e. there is possibility of arriving at wrong conclusions overestimating benefits or underestimating harms because of study design. Miniport laparoscopic cholecystectomy could be completed successfully in more than 80% of patients in most studies. The remaining patients were mostly converted to standard port laparoscopic cholecystectomy but some patients had to undergo open cholecystectomy. These patients were excluded from the analysis by the study authors and so the results of these trials as well as the present systematic review have to be interpreted with extreme caution. There was no mortality in either group in the seven trials that reported mortality (0/226 patients versus 0/234 patients). There were no significant differences between the two operation types in the proportion of patients who developed serious complications, quality of life at 10 days after operation, or in whom the laparoscopic operation had to be converted to open cholecystectomy. Miniport laparoscopic cholecystectomy took five minutes longer to complete than standard port laparoscopic cholecystectomy. There were no significant differences between the two operation types in the length of hospital stay, the time taken to return to activity, or in the time taken to return to work. There was no significant cosmetic difference at six months to 12 months after surgery between the two groups, in the two trials that reported this outcome.

There appears to be no advantage of miniport laparoscopic cholecystectomy in terms of decreasing surgical complications, hospital stay, return to activity, return to work, or improving cosmesis. On the other hand, there is a modest increase in operating time after miniport laparoscopic cholecystectomy compared with standard port laparoscopic cholecystectomy. The safety of miniport laparoscopic cholecystectomy is yet to be established. Miniport laparoscopic cholecystectomy cannot be recommended routinely outside well-designed randomised clinical trials. Further well-designed randomised clinical trials are necessary to determine whether miniport laparoscopic cholecystectomy is safe and whether there is any advantage over standard port laparoscopic cholecystectomy.

Authors' conclusions: 

Miniport laparoscopic cholecystectomy can be completed successfully in more than 80% of patients. There appears to be no advantage of miniport laparoscopic cholecystectomy in terms of decreasing mortality, morbidity, hospital stay, return to activity, return to work, or improving cosmesis. On the other hand, there is a modest increase in operating time after miniport laparoscopic cholecystectomy compared with standard port laparoscopic cholecystectomy and the safety of miniport laparoscopic cholecystectomy is yet to be established. Miniport laparoscopic cholecystectomy cannot be recommended routinely outside well-designed randomised clinical trials. Further trials of low risks of bias and low risks of random errors are necessary.

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Background: 

In conventional (standard) port laparoscopic cholecystectomy, four abdominal ports (two of 10 mm diameter and two of 5 mm diameter) are used. Recently, use of smaller ports, miniports, have been reported.

Objectives: 

To assess the benefits and harms of miniport (defined as ports smaller than the standard ports) laparoscopic cholecystectomy versus standard port laparoscopic cholecystectomy.

Search strategy: 

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013 to identify randomised clinical trials of relevance to this review.

Selection criteria: 

Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing miniport versus standard port laparoscopic cholecystectomy were considered for the review.

Data collection and analysis: 

Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using RevMan analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI).

Main results: 

We included 12 trials with 734 patients randomised to miniport laparoscopic cholecystectomy (380 patients) versus standard laparoscopic cholecystectomy (351 patients). Only one trial which included 70 patients was of low risk of bias. Miniport laparoscopic cholecystectomy could be completed successfully in more than 80% of patients in most trials. The remaining patients were mostly converted to standard port laparoscopic cholecystectomy but some were also converted to open cholecystectomy. These patients were included for the outcome conversion to open cholecystectomy but excluded from other outcomes. Accordingly, the results of the other outcomes are on 343 patients in the miniport laparoscopic cholecystectomy group and 351 patients in the standard port laparoscopic cholecystectomy group, and therefore the results have to be interpreted with extreme caution.

There was no mortality in the seven trials that reported mortality (0/194 patients in miniport laparoscopic cholecystectomy versus 0/203 patients in standard port laparoscopic cholecystectomy). There were no significant differences between miniport laparoscopic cholecystectomy and standard laparoscopic cholecystectomy in the proportion of patients who developed serious adverse events (eight trials; 460 patients; RR 0.33; 95% CI 0.04 to 3.08) (miniport laparoscopic cholecystectomy: 1/226 (adjusted proportion 0.4%) versus standard laparoscopic cholecystectomy: 3/234 (1.3%); quality of life at 10 days after surgery (one trial; 70 patients; SMD -0.20; 95% CI -0.68 to 0.27); or in whom the laparoscopic operation had to be converted to open cholecystectomy (11 trials; 670 patients; RR 1.23; 95% CI 0.44 to 3.45) (miniport laparoscopic cholecystectomy: 8/351 (adjusted proportion 2.3%) versus standard laparoscopic cholecystectomy 6/319 (1.9%)). Miniport laparoscopic cholecystectomy took five minutes longer to complete than standard laparoscopic cholecystectomy (12 trials; 695 patients; MD 4.91 minutes; 95% CI 2.38 to 7.44). There were no significant differences between miniport laparoscopic cholecystectomy and standard laparoscopic cholecystectomy in the length of hospital stay (six trials; 351 patients; MD -0.00 days; 95% CI -0.12 to 0.11); the time taken to return to activity (one trial; 52 patients; MD 0.00 days; 95% CI -0.31 to 0.31); or in the time taken for the patient to return to work (two trials; 187 patients; MD 0.28 days; 95% CI -0.44 to 0.99) between the groups. There was no significant difference in the cosmesis scores at six months to 12 months after surgery between the two groups (two trials; 152 patients; SMD 0.13; 95% CI -0.19 to 0.46).

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